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Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels

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ClinicalTrials.gov Identifier: NCT04029805
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Biosearch S.A.

Brief Summary:
The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Insulin Resistance Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 Combination Product: Placebo Phase 1 Phase 2

Detailed Description:

Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance.

The beneficial effect of the extract plant BSL-EP044 on glycemic metabolism in women with PCOS is widely studied and demonstrated and Lactobacillus BSL_PS6 appears to exert a synergistic effect by supplementing the effect of BSL-EP044. The hypothesis of our study is that the addition of the probiotic strain Lactobacillus BSL_PS6 to extract plant BSL-EP044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to PCOS.

The main objective of the present study is to evaluate the effect of the combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of a Combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on Glucidic Metabolism in Women Suffering From Polycystic Ovary Syndrome and High Insulin Levels
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination of a Plant Extract and a Probiotic
Volunteers will take twice at day for 12 weeks a capsule containing the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6
Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.

Placebo Comparator: Placebo
Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin.
Combination Product: Placebo
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.




Primary Outcome Measures :
  1. Plasma insulin [ Time Frame: 12 weeks ]
    Levels of plasma insulin

  2. Plasma glucose [ Time Frame: 12 weeks ]
    Levels of plasma glucose

  3. HOMA [ Time Frame: 12 weeks ]
    Insulin sensitivity


Secondary Outcome Measures :
  1. Total testosterone [ Time Frame: 12 weeks ]
    Total testosterone

  2. Free testosterone [ Time Frame: 12 weeks ]
    Free testosterone


Other Outcome Measures:
  1. Weight [ Time Frame: 12 weeks ]
    Weight variation throughout the study

  2. BMI [ Time Frame: 12 weeks ]
    Body mass index

  3. Blood pressure [ Time Frame: 12 weeks ]
    Systolic and diastolic pressure during the study

  4. Ovarian cycle [ Time Frame: 12 weeks ]
    Duration of the ovarian cycle



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being diagnosed with polycystic ovarian syndrome according to the Rotterdam criteria.
  • HOMA values between 2.5 and 3.
  • Body mass index of less than 35 kg/m2.
  • Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria:

  • Women in treatment with oral antidiabetics.
  • Being pregnant or intending to get pregnant.
  • Be in fertility treatment.
  • To suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029805


Contacts
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Contact: Juristo Fonollá, PhD +34958240288 Juristo.FonollaJoya@biosearchlife.com

Locations
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Spain
Clinica Margen Recruiting
Granada, Andalucia, Spain, 18006
Sponsors and Collaborators
Biosearch S.A.
Investigators
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Principal Investigator: Nicolás Mendoza, MD, PhD Professor of Gynecology at the Faculty of Medicine of the University of Granada

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Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT04029805     History of Changes
Other Study ID Numbers: P044
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Biosearch S.A.:
Polycystic ovarian syndrome
Extract plant
Probiotics
Insulin resistance
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs